Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A CONCERNING INCREASE IN SPINE SURGICAL SITE INFECTIONS (SSIS) ASSOCIATED WITH THE GUIDANCE SYSTEM ROBOT. THE INFECTION RATE HAD TRIPLED COMPARED TO FISCAL YEAR 2024, WITH SEVEN FUSION INFECTIONS REPORTED IN FY2025, FIVE OF WHICH INVOLVED PROCEDURES UTILIZING THE GUIDANCE SYSTEM ROBOT. IT WAS NOTED THAT THE INSTRUMENT WAS NOT PROPERLY CLEANED AFTER STERILIZATION, AS OBSERVED USING A BORESCOPE DOWN THE CANNULA INSERTER. IN RESPONSE TO THESE FINDINGS, THE USE OF THE GUIDANCE SYSTEM ROBOT FOR SPINE SURGERIES WAS TEMPORARILY SUSPENDED EFFECTIVE MAY 19, 2025, WHILE FURTHER INVESTIGATION AND MITIGATION EFFORTS WERE UNDERTAKEN. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PROCEDURES BEING PERFORMED WERE SACROILIAC AND THORACOLUMBAR PROCEDURES. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT MEDTRONIC FOUND NO ISSUES WITH ANY OF THE BIOLOGICS THAT WERE USED AND THE FOCUS SHIFTED TO OTHER POSSIBILITIES.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A CONCERNING INCREASE IN SPINE SURGICAL SITE INFECTIONS (SSIS) ASSOCIATED WITH THE GUIDANCE SYSTEM ROBOT. THE INFECTION RATE HAD TRIPLED COMPARED TO FISCAL YEAR 2024, WITH SEVEN FUSION INFECTIONS REPORTED IN FY2025, FIVE OF WHICH INVOLVED PROCEDURES UTILIZING THE GUIDANCE SYSTEM ROBOT. IT WAS NOTED THAT THE INSTRUMENT WAS NOT PROPERLY CLEANED AFTER STERILIZATION, AS OBSERVED USING A BORESCOPE DOWN THE CANNULA INSERTER. IN RESPONSE TO THESE FINDINGS, THE USE OF THE GUIDANCE SYSTEM ROBOT FOR SPINE SURGERIES WAS TEMPORARILY SUSPENDED EFFECTIVE MAY 19, 2025, WHILE FURTHER INVESTIGATION AND MITIGATION EFFORTS WERE UNDERTAKEN. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PROCEDURES BEING PERFORMED WERE SACROILIAC AND THORACOLUMBAR PROCEDURES. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT MEDTRONIC FOUND NO ISSUES WITH ANY OF THE BIOLOGICS THAT WERE USED AND THE FOCUS SHIFTED TO OTHER POSSIBILITIES.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A CONCERNING INCREASE IN SPINE SURGICAL SITE INFECTIONS (SSIS) ASSOCIATED WITH THE GUIDANCE SYSTEM ROBOT. THE INFECTION RATE HAD TRIPLED COMPARED TO FISCAL YEAR 2024, WITH SEVEN FUSION INFECTIONS REPORTED IN FY2025, FIVE OF WHICH INVOLVED PROCEDURES UTILIZING THE GUIDANCE SYSTEM ROBOT. IT WAS NOTED THAT THE INSTRUMENT WAS NOT PROPERLY CLEANED AFTER STERILIZATION, AS OBSERVED USING A BORESCOPE DOWN THE CANNULA INSERTER. IN RESPONSE TO THESE FINDINGS, THE USE OF THE GUIDANCE SYSTEM ROBOT FOR SPINE SURGERIES WAS TEMPORARILY SUSPENDED EFFECTIVE (B)(6) 2025, WHILE FURTHER INVESTIGATION AND MITIGATION EFFORTS WERE UNDERTAKEN. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PROCEDURES BEING PERFORMED WERE SACROILIAC AND THORACOLUMBAR PROCEDURES. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT MEDTRONIC FOUND NO ISSUES WITH ANY OF THE BIOLOGICS THAT WERE USED AND THE FOCUS SHIFTED TO OTHER POSSIBILITIES.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT WHEN INSERTING SCREWS FOR L2-L5 AND NOTING THAT LEFT L3 AND L4 WERE OFF BY A FEW MILLIMETERS LATERALLY. THE SURGEON REMOVED THE SCREWS AND REINSERTED THE SCREWS MANUALLY. THE SURGEON THEN BEGAN INSERTING SCREWS ON THE RIGHT. RIGHT L2 WAS OFF MEDIALLY AND THERE WAS A DURA TEAR. THE SURGEON DISCONTINUED USE OF THE SYSTEM AND PERFORMED THE ENTIRE RIGHT SIDE WITHOUT USE OF NAVIGATION. CC NOTED THAT A BILATERAL RETRACKER WAS PLACED ON THE PATIENT DURING REGISTRATION. IT WAS REPORTED THAT THE AMOUNT OF TRAJECTORY DEVIATION WAS UNKNOWN, BUT WAS BELIEVED TO BE LESS THAN 3.5 MILLIMETERS (MM). THERE WAS NO DELAY.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A CONCERNING INCREASE IN SPINE SURGICAL SITE INFECTIONS (SSIS) ASSOCIATED WITH THE GUIDANCE SYSTEM ROBOT. THE INFECTION RATE HAD TRIPLED COMPARED TO FISCAL YEAR 2024, WITH SEVEN FUSION INFECTIONS REPORTED IN FY2025, FIVE OF WHICH INVOLVED PROCEDURES UTILIZING THE GUIDANCE SYSTEM ROBOT. IT WAS NOTED THAT THE INSTRUMENT WAS NOT PROPERLY CLEANED AFTER STERILIZATION, AS OBSERVED USING A BORESCOPE DOWN THE CANNULA INSERTER. IN RESPONSE TO THESE FINDINGS, THE USE OF THE GUIDANCE SYSTEM ROBOT FOR SPINE SURGERIES WAS TEMPORARILY SUSPENDED EFFECTIVE (B)(6) 2025, WHILE FURTHER INVESTIGATION AND MITIGATION EFFORTS WERE UNDERTAKEN. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PROCEDURES BEING PERFORMED WERE SACROILIAC AND THORACOLUMBAR PROCEDURES. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT MEDTRONIC FOUND NO ISSUES WITH ANY OF THE BIOLOGICS THAT WERE USED AND THE FOCUS SHIFTED TO OTHER POSSIBILITIES.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE DEVIATION AMOUNT WAS AROUND 3 MILLIMETERS (MM).

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CITATION: ZHANG, H., DINGJUN, H., BAORONG, H., HONGHUI, S., ZHENGWEI, X., BIAO, W., YONGCHAO, D., WENLONG, Y., ZILIN, G., CHANGJIANG, K. (2024). COMPARISON OF THE ACCURACY AND SAFETY OF ROBOT-AND NAVIGATION-ASSISTED SCREW PLACEMENT IN ATLANTOAXIAL DISLOCATION SURGERY. NATL MED J CHINA, 104(37), 3506¿3512. HTTPS://DOI.ORG/10.3760/CMA.J.CN112137-20240329-00722 OBJECTIVE: TO COMPARE THE ACCURACY AND SAFETY OF ROBOT-ASSISTED AND NAVIGATION-ASSISTED SCREW PLACEMENT IN ATLANTOAXIAL DISLOCATION SURGERY. METHODS: A RETROSPECTIVE ANALYSIS WAS CONDUCTED ON THE CLINICAL DATA OF 49 PATIENTS WITH ATLANTOAXIAL DISLOCATION TREATED CONSECUTIVELY AT THE HONGHUI HOSPITAL OF XI'AN JIAOTONG UNIVERSITY FROM APRIL 2022 TO DECEMBER 2023. AMONG THEM, 27 WERE MALE AND 22 WERE FEMALE, AGED (44.2±11.7) YEARS. BASED ON THE DATE OF SURGERY, 29 PATIENTS (FROM APRIL 2022 TO APRIL 2023) RECEIVED THE S8 NAVIGATION-ASSISTED SCREW PLACEMENT (NAVIGATION GROUP), 20 PATIENTS (FROM MAY TO DECEMBER 2023) RECEIVED MAZOR ROBOT-ASSISTED SCREW PLACEMENT (ROBOT GROUP). THE ACCURACY OF SCREW PLACEMENT, SCREW PLACEMENT TIME, OPERATION TIME, INTRAOPERATIVE BLOOD LOSS, AND INTRAOPERATIVE COMPLICATIONS WERE RECORDED AND COMPARED B

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CITATION: ZHANG, H., DINGJUN, H., BAORONG, H., HONGHUI, S., ZHENGWEI, X., BIAO, W., YONGCHAO, D., WENLONG, Y., ZILIN, G., CHANGJIANG, K. (2024). COMPARISON OF THE ACCURACY AND SAFETY OF ROBOT-AND NAVIGATION-ASSISTED SCREW PLACEMENT IN ATLANTOAXIAL DISLOCATION SURGERY. NATL MED J CHINA, 104(37), 3506¿3512. HTTPS://DOI.ORG/10.3760/CMA.J.CN112137-20240329-00722 OBJECTIVE: TO COMPARE THE ACCURACY AND SAFETY OF ROBOT-ASSISTED AND NAVIGATION-ASSISTED SCREW PLACEMENT IN ATLANTOAXIAL DISLOCATION SURGERY. METHODS: A RETROSPECTIVE ANALYSIS WAS CONDUCTED ON THE CLINICAL DATA OF 49 PATIENTS WITH ATLANTOAXIAL DISLOCATION TREATED CONSECUTIVELY AT THE HONGHUI HOSPITAL OF XI'AN JIAOTONG UNIVERSITY FROM APRIL 2022 TO DECEMBER 2023. AMONG THEM, 27 WERE MALE AND 22 WERE FEMALE, AGED (44.2±11.7) YEARS. BASED ON THE DATE OF SURGERY, 29 PATIENTS (FROM APRIL 2022 TO APRIL 2023) RECEIVED THE S8 NAVIGATION-ASSISTED SCREW PLACEMENT (NAVIGATION GROUP), 20 PATIENTS (FROM MAY TO DECEMBER 2023) RECEIVED MAZOR ROBOT-ASSISTED SCREW PLACEMENT (ROBOT GROUP). THE ACCURACY OF SCREW PLACEMENT, SCREW PLACEMENT TIME, OPERATION TIME, INTRAOPERATIVE BLOOD LOSS, AND INTRAOPERATIVE COMPLICATIONS WERE RECORDED AND COMPARED B

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAD PERMANENT INJURIES, PAIN, SUFFERING, AND LOSS OF ENJOYMENT OF LIFE, AS A RESULT OF THE PROCEDURE.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WANDVIK, CAITLYN, ET AL. ¿LIMITATIONS OF CURRENT ROBOT-ASSISTED PEDICLE SCREW INSERTION SYSTEMS.¿ NEUROSURGICAL FOCUS, VOL. 57, NO. 6, 1 DEC. 2024, HTTPS://DOI.ORG/10.3171/2024.9.FOCUS24545. OBJECTIVE: AS ROBOT SYSTEMS FOR SPINE SURGERY HAVE BEEN DEVELOPED, THEY HAVE DEMONSTRATED A HIGH DEGREE OF ACCURACY IN SCREW PLACEMENT WITHOUT SACRIFICING SAFETY OR SURGICAL EFFICIENCY. THESE ROBOTIC SYSTEMS OFFER PREOPERATIVE PLANNING AND REAL-TIME FEEDBACK TO ENHANCE SURGICAL PRECISION AND MITIGATE HUMAN ERROR. NEVERTHELESS, LIMITATIONS TO THEIR OPTIMAL PERFORMANCE REMAIN. THE AUTHORS ANALYZED THE INITIAL 100 CASES OF PEDICLE SCREW PLACEMENTS PERFORMED USING THE MAZOR X ROBOT AT THEIR INSTITUTION, PRESENTING CASE EXAMPLES TO ILLUSTRATE THE LIMITATIONS THAT WERE EXPERIENCED, AND REVIEWED CURRENT LITERATURE ON THE LIMITATIONS OF ROBOT-ASSISTED SPINE SURGERY, EMPHASIZING THEIR IMPACT ON ACCURACY AND SAFETY. METHODS: THIS WAS A RETROSPECTIVE REVIEW OF THE FIRST 100 CASES OF ROBOT-ASSISTED PEDICLE SCREW PLACEMENT AT THE AUTHORS¿ INSTITUTION BETWEEN DECEMBER 2019 AND JUNE 2024. ALL INTRAOPERATIVE CT SCANS WERE REVIEWED FOR SCREW ACCURACY. MALPOSITIONED SCREWS, NEAR MISSES (SCREW DEVIATION WITHOUT I

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: GRIEPP, D. W., CASKEY, J., BUNJAJ, A., TURNBULL, J., ALSALAHI, A., ALEXANDER, H., DRAGONETTE, J., SARCAR, B., DESAI, S., TONG, D., SOO, T. M., BONO, P., KELKAR, P., HOUSEMAN, C., CLAUS, C. F., RICHARDS, B. F., CARR, D. A. (2024). IRRADIATION SAFETY, ANESTHESIA TIME, SURGICAL COMPLICATIONS, AND PATIENT-REPORTED OUTCOMES IN THE ROBOTIC MAZOR X VERSUS FLUOROSCOPY GUIDED MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION SURGERY: A COMPARATIVE COHORT STUDY. NEUROSURGICAL FOCUS, 57(6). HTTPS://DOI.ORG/10.3171/2024.9.FOCUS24489 OBJECTIVE: ROBOT-ASSISTED (RA) TECHNOLOGY IS BECOMING MORE WIDELY INTEGRATED AND ACCEPTED IN SPINE SURGERY. THE AUTHORS SOUGHT TO EVALUATE OPERATIVE AND PATIENT-REPORTED OUTCOMES (PROS) IN RA VERSUS FLUOROSCOPY-ASSISTED (FA) PEDICLE SCREW PLACEMENT DURING MINIMALLY INVASIVE SURGERY (MIS) TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). METHODS: THE AUTHORS RETROSPECTIVELY STUDIED ELECTIVE PATIENTS WHO UNDERWENT SINGLE- OR MULTILEVEL MIS TLIF FOR DEGENERATIVE INDICATION USING FA VERSUS RA PEDICLE SCREW PLACEMENT. PATIENTS WERE SELECTED FROM SEPTEMBER 2021 TO MAY 2023 AT A SINGLE INSTITUTION WITH MULTIPLE SURGEONS WHOSE PRACTICE CONSISTS OF PRIMARILY MIS. OUTCO

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A CERVICAL SPINE PROCEDURE. IT WAS REPORTED THAT THE DOCTOR WAS 1-2 MM OFF ON THE CERVICAL. IT WAS THE RIGHT C4 THAT THE DOCTOR FELT INACCURATE. THE PATIENT LOST BLOOD (500CC'S). BLEEDING WAS ABLE TO BE CONTROLLED. THE PROCEDURE WAS DELAYED 10 MINUTES.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE, A T10 TO T4 EXTENSION TO A PREVIOUS CONSTRUCT. IT WAS REPORTED THAT THE SURGEON STARTED INSERTING ALL SCREWS ON THE RIGHT SIDE FIRST, STARTING FROM T10 AND GOING DOWN TO T4. WHEN THE SURGEON TAPPED T4, THE NON-MEDTRONIC NEUROMONITORING SYSTEM INDICATED THAT ALL MOTOR FUNCTIONS WERE LOST IN THE PATIENT'S LOWER EXTREMITIES. THE SURGEON USED A BALL-TIP SEALER TO FEEL THAT THERE WAS NO WALL ON THE MEDIAL SIDE OF THE T4 PEDICLE. THEY WERE UNSURE WHY TAPPING WAS INACCURATE BUT SUSPECTED EITHER SKIVING OR PATIENT MOVEMENT. THEY DID NOT OBSERVE ANY SOFT TISSUE PRESSURE ON THE CANNULA NOR DEFLECTION OF THE CANNULA FROM THE GELPEE. THE SURGEON ALSO DID NOT OBSERVE ANY CEREBROSPINAL FLUID (CSF) LEAKAGE. THE SURGEON MOVED THE ROBOT OUT OF THE WAY AND USED FREEHAND NAVIGATION TO INSERT THE SCREW AT T4. THE SURGEON FELT THAT THE T4 SCREW ON THE RIGHT SIDE WAS SCREWED APPROPRIATELY. THE SURGEON THEN ABORTED NAVIGATION ENTIRELY AND PROCEEDED TO COMPLETE THE CASE BY INSERTING THE T10 THROUGH T4 SCREWS ON THE LEFT SIDE BY FREEHAND. THE SURGEON WAS FRUSTRATED BECAUSE OF THE PATIENT HARM, BUT WILL CONTINUE

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE PATIENT CODED DURING THE PROCEDURE. A TEN POINT ACCURACY CHECK WAS PERFORMED WITH NO ISSUE DETECTED. A THREE POINT ACCURACY CHECK/BIST TEST WAS PERFORMED WITH NO ISSUES DETECTED. THE SYSTEM WAS THEN BROUGHT INTO THE OPERATING ROOM(OR) FOR THE PROCEDURE. THE SCREWS WERE SET VIA K-WIRE. THE PROCEDURE WAS PERFORMED IN TWO SEGMENTS, T9-L1 AND L2 - S1. THE SURGEON EXPOSED THE TOP HALF FIRST, AND DROPPED SCREWS BILATERALLY VIA NAVIGATION. THE SCREW PLACEMENT WAS CONFIRMED VIA FLUOROSCOPY, AND THE SURGEON WAS HAPPY WITH THE SCREW PLACEMENT. THE SYSTEM WAS REMOVED FROM THE PATIENT, TO START THE SECOND SEGMENT, L2-S1. THE PATIENT HAD PREVIOUSLY INSTALLED HARDWARE IN L2-S1, SO THE SURGEON EXPOSED THE BOTTOM HALF OF THE CONSTRUCT, AND REMOVED THE OLD RODS AND SCREWS. THE SYSTEM WAS THEN RECONNECTED TO THE PATIENT, AND S2 REGISTERED WITHOUT ISSUE. K-WIRES WERE INSERTED FOR THE S2 SCREWS, AND THE SCREW WERE PLACED BILATERALLY. ALL NEW SCREWS WERE STIMULATED VIA NEUROMODULATION GREATER THAN 20. BEGINNING L2 AND MOVING TO S1, THE OLD SCREWS WERE REMOVED AND REPLACED FREEHAND.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE MISPLACED SCREWS CAUSE A LACK OF MOTION AND SENSATION FOR THE LEFT LEG SINCE THE SPINAL CORD WAS INJURED BY THE MISPLACED SCREWS. THE REPRESENTATIVE SPOKE WITH THE SURGEON ON AUGUST 14TH, AND ACCORDING TO THE SURGEON, THE CONDITION OF THE PATIENT GOT SLIGHTLY BETTER TILL THAT DAY AS HE GOT BACK SOME SENSATION AND MOTION BUT IS STILL FAR AWAY FROM BEING ABLE TO WALK NORMAL.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NILSSEN, P. K., NARENDRAN, N., SKAGGS, D. L., TUCHMAN, A., WALKER, C. T., & PERRY, T. G. (2024). COMPARISON OF ROSTRAL FACET JOINT VIOLATIONS IN ROBOTIC- AND NAVIGATION-ASSISTED PEDICLE SCREW PLACEMENT FOR ADULT LUMBAR SPINE INSTRUMENTATION. THE SPINE JOURNAL. HTTPS://DOI.ORG/10.1016/J.SPINEE.2024.07.008 SUMMARY: BACKGROUND CONTEXT: FACET JOINT VIOLATION BY PEDICLE SCREWS MAY LEAD TO ADJACENT-SEGMENT DISEASE AND POSTOPERATIVE PAIN. PREVIOUS STUDIES HAVE REPORTED THE INCIDENCE OF ROSTRAL FACET JOINT VIOLATION USING VARIOUS PEDICLE SCREW INSERTION TECHNIQUES. HOWEVER, THE INCIDENCE OF FACET JOINT VIOLATIONS WITH ROBOTIC GUIDANCE HAS NOT BEEN DETERMINED. PURPOSE: TO INVESTIGATE AND COMPARE THE INCIDENCE OF ROSTRAL FACET JOINT VIOLATION BY PEDICLE SCREWS UNDER ROBOTIC GUIDANCE AND COMPUTERIZED TOMOGRAPHY (CT) NAVIGATION GUIDANCE. STUDY DESIGN/SETTING: RETROSPECTIVE MATCHED COHORT. PATIENT SAMPLE: ALL PATIENTS WHO UNDERWENT ROBOTIC-ASSISTED LUMBAR FUSION AT A MAJOR SPINE CENTER UP UNTIL 2023 WERE RETROSPECTIVELY IDENTIFIED AND MATCHED 1:3 TO PATIENTS UNDERGOING CT NAVIGATION GUIDANCE BASED BY ON AGE, SEX, ROSTRAL VERTEBRAL LEVEL, AND LENGTH OF CONSTRUCT. INCLUSION CRITERIA CONSISTED OF

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: TONG, M., ZHANG, S., ZHANG, W., MOU, L., DONG, Z., WANG, R., LI, S., <(>&<)> HUANG, Y. (2024). EFFICACY AND SAFETY OF NAVIGATION ROB OT-ASSISTED VERSUS CONVENTIONAL OBLIQUE LATERAL LUMBAR INTERBODY FUSION WITH INTERNAL FIXATION IN THE TREATMENT OF LUMBAR DEGENERATIVE DISEASES: A RETROSPECTIVE STUDY. MEDICINE, 103(32). HTTPS://DOI.ORG/10.1097/MD.0000000000039261 SUMMARY: EFFECTIVE INTERNAL FIXATION WITH PEDICLE SCREW IS A KEY FACTOR IN THE SUCCESS OF LUMBAR FUSION WITH INTERNAL FIXATION. WHETHER NAVIGATION ROBOTS CAN IMPROVE THE EFFICACY AND SAFETY OF SCREW PLACEMENT IS CONTROVERSIAL. THIRTY-EIGHT PATIENTS WHO UNDERWENT OBLIQUE LATERAL LUMBAR INTERBODY FUSION INTERNAL FIXATION FROM MARCH 2022 TO MAY 2023 WERE RETROSPECTIVELY ANALYZED, 16 CASES IN THE NAVIGATIONAL ROBOT GROUP AND 22 CASES IN THE FLUOROSCOPY GROUP. USING VISUAL ANALOG SCORE (VAS) FOR THE LOW BACK AND LOWER LIMBS, OSWESTRY DISABILITY INDEX TO COMPARE THE CLINICAL EFFICACY OF THE 2 GROUPS; USING PERIOPERATIVE INDEXES SUCH AS THE DURATION OF SURGERY, INTRAOPERATIVE BLOOD LOSS, INTRAOPERATIVE FLUOROSCOPY TIMES, AND POSTOPERATIVE HOSPITAL STAY TO COMPARE THE SAFETY OF THE 2 GROUPS; AND USING ACCURACY OF PEDICLE SCREWS (APS

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION WAS RECEIVED. THE AMOUNT OF DEVIATION WAS UNKNOWN BY THE SITE.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING A REVISION OF T7 TO L2, WITH AN EXTENSION OF FUSION FROM T4 TO T7, USING A "UNID" ROD USING THE CT TO FLUORO WORKFLOW, THERE WAS AN ALLEGED INACCURACY. AFTER DISCUSSING THE CASE WITH THE SURGEON, IT WAS DECIDED THAT THEY WOULD BE PLACING SCREWS IN T4, T5, AND T6, AND REMOVING THE EXISTING HARDWARE AT T7 AND T8 AND REDIRECTING AND REPLACING THE SCREWS AT T7 AND T8. WHILE REGISTERING THE PATIENT TO THE ROBOTIC SYSTEM, THEY HAD GOTTEN SEGMENTATION ON THEIR FIRST AP AND OBLIQUE SHOTS, BUT WHEN IT WENT TO THE REGISTRATION, THEY GOT RED VALUES AT ALL LEVELS (T4-T8). THEY ADJUSTED THE NON-MEDTRONIC IMAGING SYSTEM AND TOOK A NEW OBLIQUE IMAGE AND THEY WERE ABLE TO GET SEGMENTATION AND GREEN VALUES ON THE SECOND REGISTRATION ATTEMPT. THEY CHECKED FOR SHIFTS AND NONE WERE NOTED SO THEY PROCEEDED TO THE OPERATE PORTION. THEY STARTED WITH T4 ON THE RIGHT AND WORKED THEIR WAY DOWN THE RIGHT SIDE, PLACING SCREWS IN T4, T5, AND T6. THE NEUROMONITORING TEAM RAN A MOTOR TEST AFTER THEY PUT IN THE 3 SCREWS ON THE RIGHT SIDE AND THERE WERE NO CHANGES. THE SITE THEN SWITCHED TO

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: GERLING, M., BAKER, M., STANTON, E., PYUN, J., CHALADOFF, E., PASSIAS, P., <(>&<)> BUSER, Z. (2024). CLOSING THE GAP: THE INCIDENCE OF COMPLICATIONS IN MINIMALLY INVASIVE TUBULAR, ENDOSCOPIC, AND ROBOTIC-ASSISTED TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURES. WORLD NEUROSURGERY. HTTPS://DOI.ORG/10.1016/J.WNEU.2024.06.101 SUMMARY: BACKGROUND: THE AIM OF THE CURRENT STUDY WAS TO COMPARE THE INCIDENCE OF POSTOPERATIVE COMPLICATIONS AMONG MINIMALLY INVASIVE SURGERY (MIS) TUBULAR, ENDOSCOPIC, AND ROBOT-ASSISTED TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) TECHNIQUES. METHODS: WE STUDIED CONSECUTIVE PATIENTS WHO UNDERWENT SINGLE-LEVEL OR MULTILEVEL TLIF BETWEEN 2020 AND 2022. PREOPERATIVE AND POSTOPERATIVE PATIENT-REPORTED OUTCOMES (VISUAL ANALOG SCALE LEG SCORE AND OSWESTRY DISABILITY INDEX), DEMOGRAPHIC, AND INTRAOPERATIVE VARIABLES WERE RECORDED. ONE-WAY ANALYSIS OF VARIANCE WITH BARTLETT¿S EQUAL-VARIANCE AND PEARSON CHI-SQUARED TESTS WERE USED. RESULTS: THE STUDY INCLUDED 170 TLIF PATIENTS: 107 (63%) TUBULAR, 42 (25%) ENDOSCOPIC, AND 21 (12%) ROBOT ASSISTED. ALL 3 TLIF TECHNIQUES HAD SIMILAR COMPLICATION RATES: TUBULAR 6 (5.6%), ENDOSCOPIC 2 (4.8%), AND ROBOT ASSISTED 1 (4.8%) A

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CITATION: SRINIVASA, V., THIRUGNANAM, B., PAI KANHANGAD, M., SONI, A., KASHYAP, A., VIDYADHARA, A., & RAO, S. K. (2024). FLATTENING THE LEARNING CURVE ¿ EARLY EXPERIENCE OF ROBOTIC-ASSISTED PEDICLE SCREW PLACEMENT IN SPINE SURGERY. JOURNAL OF ORTHOPAEDICS, 57, 49¿54. HTTPS://DOI.ORG/10.1016/J.JOR.2024.06.011. SUMMARY: AIMS AND OBJECTIVES: TO DETERMINE ACCURACY OF PEDICLE SCREWS PLACED BY FREEHAND, FLUOROSCOPY-ASSISTANCE AND ROBOTIC-ASSISTANCE WITH INTRAOPERATIVE IMAGE ACQUISITION, AND DETERMINE THE PRESENCE OF LEARNING CURVE IN ROBOTIC SPINE SURGERY IN A PROSPECTIVE SINGLE CENTRE STUDY. MATERIALS AND METHODS: IN A PROSPECTIVE STUDY, A TOTAL OF 1120 PEDICLE SCREWS WERE PLACED IN FREEHAND GROUP (N = 175), 1250 SCREWS WERE PLACED IN FLUOROSCOPY ASSISTED GROUP (N = 172), AND 1225 SCREWS WERE INSERTED IN ROBOTIC-ASSISTED GROUP(N = 180). SURGICAL PARAMETERS AND SCREW ACCURACY WERE ANALYZED BETWEEN THE THREE GROUPS. THE PREOPERATIVE PLAN WAS OVERLAPPED WITH POST OPERATIVE O-ARM SCAN TO DETERMINE IF THE SCREWS WERE EXECUTED AS PLANNED. RESULTS: THE FREQUENCY OF CLINICALLY ACCEPTABLE SCREW PLACEMENT (GERTZBEIN AND ROBBINS GRADE A, B) IN THE FREEHAND, FLUOROSCOPY-ASSISTED, AND ROBOTIC-ASSIST

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM. IT WAS REPORTED THAT THE PATIENT HAD POST-PROCEDURE ACUTE BLOOD LOSS, ANEMIA, AND THEIR HEMOGLOBIN WAS REPORTED AS 9.0 MILLIGRAMS (MG) PER DECILITER. THE ESTIMATED BLOOD LOSS (EBL) WAS REPORTED AS 1,000 MILLILITERS (ML). DIAGNOSTIC TESTS WERE PERFORMED AND THE ADVERSE EVENT RESULTED IN TREATMENT AND A NEUROLOGICAL EXAM WAS COMPLETED. THE PATIENT RECEIVED 2 UNITS OF TRANSFUSED PACKED RED BLOOD CELLS AND RECOVERED ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED INDICATED THE SURGERY BEING PERFORMED WAS FOR SPINAL DEGENERATIVE DISEASE AND THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2024.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WERTHMANN, N. J., GUM, J. L., NAGATA, K., DJURASOVIC, M., GLASSMAN, S. D., OWENS, R. K., CRAWFORD, C. H., <(>&<)> CARREON, L. Y. (2024). COMPARISON OF NO TAP (TWO-STEP) AND TAPPING ROBOTIC ASSISTED CORTICAL BONE TRAJECTORY SCREW INSERTION. JOURNAL OF ROBOTIC SURGERY, 18(1). HTTPS://DOI.ORG/10.1007/S11701-024-01890-1 SUMMARY: WORKFLOW FOR CORTICAL BONE TRAJECTORY (CBT) SCREWS INCLUDES TAPPING LINE-TO-LINE OR UNDER TAPPING BY 1 MM. WE DESCRIBE A NON-TAPPING, TWO-STEP WORKFLOW FOR CBT SCREW PLACEMENT, AND COMPARE THE SAFETY PROFILE AND TIME SAVINGS TO THE TAP (THREE STEP) WORKFLOW. PATIENTS UNDERGOING ROBOTIC ASSISTED 1¿3 LEVEL POSTERIOR FUSION WITH CBT SCREWS FOR DEGENERATIVE CONDITIONS WERE IDENTIFIED AND SEPARATED INTO EITHER A NO-TAP OR TAP WORKFLOW. NUMBER OF TOTAL SCREWS, SCREW-RELATED COMPLICATIONS, ESTIMATED BLOOD LOSS, OPERATIVE TIME, ROBOTIC TIME, AND RETURN TO THE OPERATING ROOM WERE COLLECTED AND ANALYZED. THERE WERE 91 CASES (458 SCREWS) IN THE NO-TAP AND 88 CASES (466 SCREWS) IN THE TAP GROUPS, WITH NO DIFFERENCE IN DEMOGRAPHICS, REVISION STATUS, ASA GRADE, APPROACH, NUMBER OF LEVELS FUSED OR DIAGNOSIS BETWEEN COHORTS. TOTAL ROBOTIC TIME WAS LOWER IN THE NO-TAP (26.7 MIN

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CITATION: HTTPS://DOI.ORG/10.1016/J.WNSX.2024.100390 SUMMARY: BACKGROUND: ROBOTIC-ASSISTED, ENDOSCOPIC TRANSFORAMINAL LUMBAR INTERBODY FUSION (RE-TLIF) IS A PROMISING, MINIMALLY INVASIVE SURGICAL OPTION FOR DEGENERATIVE LUMBAR SPONDYLOSIS/SPONDYLOLISTHESIS; HOWEVER, OUTCOMES DATA AND EFFICACY ARE LIMITED, ESPECIALLY IN MULTILEVEL DISEASE. HERE, WE PRESENT THE FIRST REPORTED SERIES OF PATIENTS THAT UNDERWENT EITHER SINGLE OR MULTILEVEL RE-TLIF. METHODS: A RETROSPECTIVE REVIEW WAS PERFORMED ON 23 CONSECUTIVE PATIENTS WHO UNDERWENT A SINGLE LEVEL OR MULTILEVEL RE-TLIF BY A SINGLE SURGEON. VARIABLES INCLUDED DEMOGRAPHICS, PERIOPERATIVE RESULTS, PAIN SCORES, AND FUNCTIONAL OUTCOME SCORES. RESULTS: EIGHTEEN PATIENTS (78.3 %) UNDERWENT SINGLE LEVEL RE-TLIF AND 5 PATIENTS (21.7 %) UNDERWENT MULTILEVEL RE-TLIF. THE MEDIAN REDUCTION OF VISUAL ANALOG SCALE (VAS) FOR LOW BACK PAIN (LBP) OF ALL SUBJECTS WAS 6 (IQR = 4.5, 6.5) WITH NO SIGNIFICANT DIFFERENCE BETWEEN SINGLE LEVEL AND MULTILEVEL RE-TLIF (P = 0.565). THE MEDIAN REDUCTION OF VAS FOR LEG PAIN OF ALL SUBJECTS 7 (IQR = 6, 8) WITH NO SIGNIFICANT DIFFERENCE BETWEEN SINGLE LEVEL AND MULTILEVEL RE-TLIF (P = 0.702). MEDIAN BLOOD LOSS WAS 25

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WIDMANN, R. F., WISCH, J. L., TRACEY, O. C., ZUCKER, C. P., FEDDEMA, T., MILLER, F., LINDEN, G. S., ERICKSON, M., & HEYER, J. H. (2024). ANALYSIS OF 5,070 CONSECUTIVE PEDICLE SCREWS PLACED UTILIZING ROBOTICALLY ASSISTED SURGICAL NAVIGATION IN 334 PATIENTS BY EXPERIENCED PEDIATRIC SPINE DEFORMITY SURGEONS: SURGICAL SAFETY AND EARLY PERIOPERATIVE COMPLICATIONS IN PEDIATRIC POSTERIOR SPINAL FUSION. SPINE DEFORMITY. HTTPS://DOI.ORG/10.1007/S43390-024-00854-7 PURPOSE: THIS STUDY EVALUATES THE INTRAOPERATIVE AND SHORT-TERM COMPLICATIONS ASSOCIATED WITH ROBOTICALLY ASSISTED PEDICLE SCREW PLA CEMENT IN PEDIATRIC POSTERIOR SPINAL FUSION (PSF) FROM THREE SURGEONS AT TWO DIFERENT INSTITUTIONS. METHODS: WE RETROSPECTIVELY REVIEWED 334 PEDIATRIC PATIENTS WHO UNDERWENT PSF WITH ROBOTIC-ASSISTED NAVIGATION AT 2 INSTITUTIONS OVER 3 YEARS (2020¿2022). FIVE THOUSAND SEVENTY ROBOTICALLY PLACED SCREWS WERE EVALUATED. DATA COLLECTION FOCUSED ON INTRAOPERATIVE AND EARLY POSTOPERATIVE COMPLICATIONS WITH MINIMUM 30-DAY FOLLOW-UP. PATIENTS UNDERGOING REVISION PROCEDURES WERE EXCLUDED. RESULTS: INTRAOPERATIVE COMPLICATIONS INCLUDED 1 DUROTOMY, 6 PATIENTS WITH NEUROMONITORING ALERTS NOT RELATED TO SCREW PLAC

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING A PEDIATRIC SCOLIOSIS SURGERY, THE SURGEON PLANNED A T3-L2 SCAN AND PLAN WORKFLOW AND THE SURGEON EXPOSED T2-L3. AFTER EXPOSURE, THE SURGEON FREEHANDED THE LEFT L2 SCREW AND PLACED A FIDUCIAL MARKER IN LAMINA AT T10 (LAMINA IS A TECHNIQUE THE SURGEON USES TO HELP VERIFY ACCURACY). THE SPINOUS PROCESS CLAMP WAS ATTACHED ON THE SPINOUS PROCESS OF L2 AND CONNECTED THE SURGICAL ARM TO THE PATIENT WITH A STANDARD BRIDGE. THE AIRFRAME WAS PLACED WITH A DOUBLE SPINOUS PROCESS CLAMP AT T3 AND T4. A 3DEFINE SCAN SNAPSHOT WITH NAVIGATION AIRFRAME WAS THEN PERFORMED. THE STAR MARKER WAS PLACED AND A SUCCESSFUL IMAGING SPIN WAS TAKEN. THE SPIN WAS TRANSFERRED TO THE GUIDANCE SYSTEM VIA THUMB DRIVE. THE SURGEON ASSISTED WITH SCREW PLANNING ¿ IT WAS PLANNED AT T8-L1 ON THE LEFT SIDE (L2 WAS PLACED FREEHAND PRIOR) AND PLANNED T8-L2 ON THE RIGHT. THE SURGEON STARTED PLACING SCREWS ROBOTICALLY AT LEFT L1 AND WORKING CRANIALLY TO T8. THEY WERE PERIODICALLY CHECKING THE ROBOTIC AND NAVIGATION ACCURACY ON PATIENT'S ANATOMY, THE DIVOT ON THE ARM GUIDE, AND ROBOTICALLY BY SENDING

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PHAM, M. H., HERNANDEZ, N. S., & STONE, L. E. (2024). PREOPERATIVE ROBOTICS PLANNING FACILITATES COMPLEX CONSTRUCT DESIGN IN ROBOT-ASSISTED MINIMALLY INVASIVE ADULT SPINAL DEFORMITY SURGERY¿A PRELIMINARY EXPERIENCE. JOURNAL OF CLINICAL MEDICINE, 13(7), 1829. HTTPS://DOI.ORG/10.3390/JCM13071829. BACKGROUND: THE CORRECTION OF ADULT SPINAL DEFORMITY (ASD) CAN REQUIRE LONG, COMPLEX CONSTRUCTS WITH MULTIPLE RODS WHICH TRAVERSE IMPORTANT BIOMECHANICAL LEVELS TO ACHIEVE MULTI-PELVIC FIXATION. MINIMALLY INVASIVE (MIS) PLACEMENT OF THESE CONSTRUCTS HAS HISTORICALLY BEEN DIFFICULT. ADVANCED TECHNOLOGIES SUCH AS SPINAL ROBOTICS PLATFORMS CAN FACILITATE THE DESIGN AND PLACEMENT OF THESE CONSTRUCTS AND FURTHER ENABLE THESE SURGICAL APPROACHES IN MIS DEFORMITY SURGERY. METHODS: A RETROSPECTIVE STUDY WAS PERFORMED ON A SERIES OF ASD PATIENTS UNDERGOING MIS DEFORMITY CORRECTION WITH =EIGHT FUSION LEVELS TO THE LOWER THORACIC SPINE WITH PREOPERATIVE ROBOTIC CONSTRUCT PLANNING AND ROBOT-ASSISTED PEDICLE SCREW PLACEMENT. RESULTS: THERE WERE 12 PATIENTS (10 FEMALE, MEAN AGE 68.6 YEARS) WITH A DIAGNOSIS OF EITHER DEGENERATIVE SCOLIOSIS (8 PATIENTS) OR SAGITTAL IMBALANCE (4 PATIENTS). ALL UNDERWENT PREO

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ALLEGED SCREW DEVIATION IN A SCAN AND PLAN CASE. THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE PATIENT WAS HAVING MULTIPLE SCREWS PLACED FROM THE THORACIC TO THE LUMBAR VERTEBRAE FOR A SCOLIOSIS PROCEDURE. THE REP REPORTED THAT MULTIPLE ACCURACY CHECKS WERE PERFORMED, HOWEVER, WHEN T4 ON THE RIGHT SIDE WAS DRILLED, THE PATIENT'S MOTOR WAS TESTED AND WAS ABSENT. WHEN A POST SURGICAL SCAN WAS PERFORMED, THE SCREW PLACED IN T5 WAS POTENTIALLY DEVIATED BY 1-2 MILLIMETERS (MM), BUT PER THE REP, THE SURGEON BELIEVED THAT THE T4 DRILL WAS ACCURATE AND THAT THE PEDICLE FRACTURED ON THE RIGHT SIDE. ALL OTHER SCREWS PLACED IN THE LEFT AND RIGHT VERTEBRAE APPEARED ACCURATE IN THE SOFTWARE. THERE WAS NO SURGICAL DELAY TIME AND THE PATIENT WAS AFFECTED.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative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

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE REMOVAL OF THE NAIL WAS AN ADDITIONAL SURGERY.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT WHILE USING THE NEW 5.1.1 SOFTWARE, THE NAVIGATION WAS SHOWING THE SCREW HIT THE BULLSEYE DEPTH, BUT THE SCREW WAS STILL PROUD. THE SURGEON CHECKED THE DEPTH WITH A PROBE AND BELIEVED IT WAS AT 40MM DEEP, INSTEAD OF 50 MM DEEP. THE SNAPSHOT WAS REDONE TO MAKE SURE ACCURACY WAS GOOD. THE SITE TOUCHED THE LAMINA WITH THE PASSIVE PLANAR PROBE AND THE SYSTEM SHOWED THAT IT WAS 5-10 MM PAST WHERE IT WAS LOCATED. AN ACCURACY CHECK ON THE DIVOT OF THE ARM GUIDE WAS MATCHING. THE REGISTRATION WAS REDONE AND THE SITE HAD TO AIRPLANE THE BED TO CONFIRM HOW DEEP THE SCREWS ACTUALLY WERE AND THEY WERE ABLE TO SEE THERE WAS PLENTY OF ROOM LEFT. WHEN AIRPLANING THE BED, THE SITE BELIEVED THE PATIENT ANATOMY SHIFTED SO THE ORIGINAL PILOT HOLE WAS INFERIOR AND MEDIAL. DURING THE LEFT L3 SEGMENT, THE SURGEON B REACHED THE INTERVERTEBRAL CANAL AND CENTRAL CANAL. NEUROMONITORING INDICATED SIGNAL LOSS ON THE LEFT SIDE. DESPITE THE CHALLENGES, THE PATIENT DID REGAIN THE ABILITY TO MOVE THEIR LEGS POST-OPERATION. DURING THE LEFT L3 PART, THE NAVIGATION SYSTEM INDICATED A 5 MM INSTRUMENT

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NAGATA, K., GUM, J. L., BROWN, M., DANIELS, C., HINES, B., CARREON, L. Y., GLASSMAN, S. D. (2024). RISK FACTORS FOR MEDIAL BREACH DURING ROBOTIC-ASSISTED CORTICAL BONE TRAJECTORY SCREW INSERTION. WORLD NEUROSURGERY, 184. HTTPS://DOI.ORG/10.1016/J.WNEU.2024.01.168 OBJECTIVE: WE DESCRIBE THE INCIDENCE OF, AND IDENTIFY THE RISK FACTORS FOR, A MEDIAL BREACH OF THE PEDICLE WALL DURING ROBOTIC-ASSISTED CORTICAL BONE TRAJECTORY (RA-CBT) SCREW INSERTION. METHOD: WE ANALYZED A CONSECUTIVE SERIES OF ADULT PATIENTS WHO UNDERWENT RA-CBT SCREW PLACEMENT FROM JANUARY 2019 TO JULY 2022. TO ASSESS THE PEDICLE WALL MEDIAL BREACH, POSTOPERATIVE COMPUTED TOMOGRAPHY (CT) IMAGES WERE ANALYZED. PATIENT DEMOGRAPHIC DATA AND SCREW DATA WERE COMPARED BETWEEN PATIENTS WITH AND WITHOUT A MEDIAL BREACH. THE HOUNSFIELD UNITS (HUS) ON THE L1 MIDVERTEBRAL AXIAL CT SCAN WAS USED TO EVALUATE BONE QUALITY. RESULT: OF 784 CBT SCREWS IN 145 PATIENTS, 30 (3.8%) HAD A MEDIAL BREACH IN 23 PATIENTS (15.9%). ONE SCREW WAS GRADE 2, AND THE OTHERS WERE GRADE 1. PATIENTS WITH A MEDIAL BREACH HAD A LOWER HU VALUE COMPARED WITH THE PATIENTS WITHOUT A MEDIAL BREACH (123.3 VS. 150.5; P [0.027). A MEDIAL BREACH WAS MORE COMMON IN

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SURGEON CAUSED A TEAR OF THE SPINAL MEMBRANE(DUROTOMY) DUE TO DEVIATED PLACEMENT OF THE LEFT PEDICLE SCREW. THE SURGEON FELT THE CAUSE OF THE DEVIATED SCREW PLACEMENT WAS DUE TO A MALFUNCTION WITH THE GUIDANCE SYSTEM. THE PATIENT'S SPINAL CORD MEMBRANE WAS TORN APART, RESULTING IN SIGNIFICANT PERMANENT INJURIES INCLUDING EPIDURAL HEMATOMA, INTRADURAL COMPRESSIVE FLUID COLLECTION, SEVERED LUMBAR NERVE ROOTS, LOSS OF USE OF LIMBS, FOOT DROP, INCONTINENCE, AND OTHER INJURIES CONSISTENT WITH CAUDA EQUINA SYNDROME. THE PATIENT HAS ALSO EXPERIENCED PAIN AND MENTAL ANGUISH.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT A SURGEON DECIDED TO BRING A PATIENT BACK TO REVISE TWO SCREWS. THE SCOPE WAS TO IMPLANT EIGHT SCREWS FROM L2 TO L5. THE SITE INITIALLY ATTEMPTED TO REGISTER USING CT TO FLUORO, BUT THAT REGISTRATION FAILED SIX TIMES DUE TO THREE TITANIUM CAGES BEING IN THE FIELD OF VIEW AND THE PATIENT BEING VERY LARGE. THE SURGEON EXPECTED TO FAIL THAT REGISTRATION DUE TO THE CAGES IN THE VIEW AND THE PATIENT BEING VERY LARGE. THE SURGEON HAD BEEN SUCCESSFUL IN ACQUIRING A PASSING REGISTRATION IN THIS CIRCUMSTANCE BEFORE WHICH IS WHY THEY KEPT TRYING TO GET A REGISTRATION. AFTER THE SURGEON FELT LIKE THEY HAD GIVEN CT TO FLUORO REGISTRATION A CHANCE, THE SITE RESORTED TO USING SCAN AND PLAN INSTEAD. SCAN AND PLAN REGISTRATION WAS SUCCESSFUL. THE SURGEON INSERTED THE EIGHT SCREWS AND COMPLETED THE CASE. THE SURGEON VERIFIED THE SCREW PLACEMENT AFTER THE CASE USING FLUORO. HOWEVER, THE SURGEON ORDERED A CT OF THE PATIENT AFTER THE CASE, WHICH MADE THEM REALIZE TWO OF THE EIGHT SCREWS WERE TOO SUPERIOR. THE TRAJECTORY WAS DEVIATED 3.5 MM TO 10MM. THE SURGEON THEN DECIDED TO SCHEDULE

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT AFTER THE SCREW INSERTIONS AND DURING DECOMPRESSION, THE SURGEON NOTICED A DURAL TEAR DUE TO A SCREW BEING INSERTED TOO MEDIALLY. THE SURGEON REINSERTED THE SCREW WITHOUT USING THE GUIDANCE SYSTEM. THE SURGEON ALLEGED THE TEAR WAS CAUSED BY THE MEDIAL SCREW AND THAT THE SCREW WAS NOT INSERTED ACCORDING TO THE PLAN. ALL SCREWS WERE PLACED CORRECTLY EXCEPT FOR THE LAST SCREW, WHICH WAS ON L1. THE DEVIATION WAS LESS THAN 3.5MM. THE SCREW WAS REPOSITIONED VIA FREEHAND. THE PATIENT EXPERIENCED WEAKNESS IN BOTH LEGS, BUT IS GETTING BETTER. THE PROCEDURE WAS NOT DELAYED.